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Clinical Trials in Canada / NCT06743581
Recruiting Not applicable

Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer

NCT06743581 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-08-19
Last updated
2026-08-17

Condition(s) studied

Non-Small Cell Lung CancerImmunotherapyNeoadjuvant Therapy

Investigational drug(s) / intervention(s)

Cemiplimab →Dupilumab →

Cemiplimab: Cemiplimab 350 mg administered intravenously on day 1

Dupilumab: Dupilumab 600 mg administered subcutaneously on day 1

Study summary

This phase 1b/2a study evaluates the safety, feasibility, and efficacy of combining dupilumab (anti-IL-4Rα) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. Phase 1b focuses on safety and feasibility, using a 3+3 design to monitor dose-limiting toxicities (DLTs), while Phase 2a assesses the major pathological response (MPR) rate with a Simon's two-stage minimax design. Secondary endpoints include event-free survival, overall survival, and translational objectives such as deep immune monitoring from patient samples, with the trial expected to enroll 24 patients at CHUM over five years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histological confirmation of NSCLC is required before treatment (however, patients with a smoking history and radiographic findings suggestive of NSCLC may consent prior to biopsy to combine research and diagnostic procedures. * Age ≥ 18 years. * ECOG performance status 0-1 * Determined to be a surgical candidate for tumor resection by a multidisciplinary team. * Women of childbearing potential and men must use approved contraception during the study and for 4 months post-treatment. Pregnancy or suspected pregnancy must be reported immediately. * Adequate organ and marrow function. * Pre-treatment biopsies are mandatory, and tumors must be T1b or larger (\>1cm) and amenable to biopsy as determined by a multidisciplinary team. * Patients must consent to provide blood at designated study time points. * Patients must consent to core needle biopsies (at least 3 samples, as deemed safe by the performing surgeon/radiologist) prior to treatment initiation Exclusion Criteria: * History of autoimmune disorders or use of immunomodulatory drugs (including dupilumab) within 2 months prior to treatment initiation. * Active autoimmune disease requiring systemic treatment in the past year, excluding replacement therapies like thyroxine or insulin. * Use of immunosuppressive drugs or systemic steroids within 7 days prior to treatment, except chronic steroids ≤10mg prednisone or equivalent. * No smoking history or confirmed tissue or ctDNA evidence of actionable driver alterations (e.g. EGFR mutation, ALK, or ROS1 rearrangements) * Prior chemotherapy or radiotherapy for another primary tumor, or prior locoregional therapy to the target lesion. Therapy for a different cancer is acceptable. * Metastatic disease where surgery would not have curative intent. * Uncontrolled illness, including active infections requiring antibiotics, symptomatic heart failure, unstable angina, or psychiatric/social conditions impeding study compliance. * Pregnancy or nursing, due to potential harm to the fetus or infant. * Progressive malignancy requiring active treatment, except for certain stable cancers treated with curative intent * HIV infection with detectable viral load or not on a stable HAART regimen * Active Hepatitis B or C (PCR-detectable) * History of allogeneic hematopoietic or solid organ transplantation. * Documented hypersensitivity to protein therapeutics. * Any condition, therapy, or abnormality that may interfere with trial results, patient participation, or their best interest as per the investigator's judgment.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
CHUM Montreal Quebec Recruiting
Centre hospitalier de l'Université de Montréal (CHUM) Montreal Quebec Not Yet Recruiting

On this site

📄 Libtayo (cemiplimab) drug profile → 📄 Dupixent (dupilumab) drug profile →

More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06743581 on ClinicalTrials.gov ↗ ← All trials in Canada